| NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 12-264 |
| Extent | Complete standard |
| Standards Orgs | NEMA National Electrical Manufacturers Association https://www.nema.org/ |
| STG | Radiology |
| FDA Tech | Ting Song FDA/OMPT/CDRH/OIR/DRH/MREP/ 301-796-7677 ting.song@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This document defines methods for determining the gradient -induced electric fields of diagnostic magnetic resonance imaging gradient coils (head and body) under a specific set of conditions. This document does not address the effect of electrical inhomogeneities in the body on internal, gradient - induced, electric fields.
| Regulation Number | Device Name | Device Class | Product Code |
| §892.1000 | Coil, Magnetic Resonance, Specialty | Class 2 | MOS |
| §892.1000 | System, Nuclear Magnetic Resonance Imaging | Class 2 | LNH |
| §892.1000 | System, Nuclear Magnetic Resonance Spectroscopic | Class 2 | LNI |
| Guidance for Industry Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. Document issued on: November 14, 1998 Guidance for Industry and FDA Staff Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices. Document issued on: July 14, 2003 |